NIAAA Natural History Protocol
Key facts
- Who runs it
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 7,500 people, planned
- Started
- 21 Jan 2015
- Expected to end
- 31 Dec 2044
- Type of study
- Observational, 2 groups
- Record updated
- 5 November 2026
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who cannot take part
- Individuals < 18 years of age
- Candidates having a severe medical or mental health disorder that would impair participation in the study; All participants are initially phone-screened for eligibility: age, legal status, pregnancy, and severe medical conditions will be assessed using information reported in the phone screen to determine eligibility for the study
- This is a natural history protocol of alcohol use as a continuum. Potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants for this protocol:
- Prisoners
- Pregnant candidates
Other criteria
- INCLUSION CRITERIA:; As this is a natural history protocol of alcohol use as a continuum, in order to be eligible to participate in this study, an individual must meet the following criterion:
- Age >=18 years of age
- Willingness to complete the study including genetic and MRI tests; We will assign participants to one of two groups in this study:
- Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and
- Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use); All participants are initially phone-screened for eligibility and their desire for treatment of AUD (or lack of it) will determine their group allocation. Their self-report of health status, pregnancy, legal status, and willingness to complete the study including the genetics and MRI test will be assessed in the phone screen and determine eligibility
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: Beth A Lee, R.N.Taking people
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems.
Objective:
-To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center.
Eligibility:
* Adults age 18 and older. * Not being pregnant or imprisoned.
Design:
* Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests. * Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research. * Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time. * Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both. * After discharge, participants may be called and asked questions about their drinking and health. * If participants sign the second consent, they: * will complete paper- and computer-based questionnaires. * will give blood samples. * may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.
The 2 groups in the trial
- Not treatment-seeking participants
Individuals who meet current or past DSM 5 criteria for AUD but are not seeking treatment. Healthy volunteers and other volunteers.
- Treatment-seeking Patients
Individuals who meet current DSM 5 criteria for AUD and are seeking treatment for it.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT02231840, who can take part
- Record updated
- 5 November 2026